SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Absorption and

EliminationAfter administration of sodium sulfate, potassium sulfate and magnesium sulfate oral solution in six healthy subjects, the time at which serum sulfate reached its highest point (T max ) was approximately 17 hours after the first dose or approximately 5 hours after the second dose, and then declined with a half-life of 8.5 hours.

ExcretionFecal excretion was the primary route of sulfate elimination. Specific Populations Patients with Renal Impairment The disposition of...

Adults The colon cleansing efficacy of sodium sulfate, potassium sulfate and magnesium sulfate oral solution was evaluated in a randomized, single-blind, active-controlled, multicenter study in adult patients scheduled to have a colonoscopy. There were 363 adult patients included in the efficacy analysis. Patients ranged in age from 20 to 84 years (mean age 55 years) and 54% were female. Race distribution was 86% Caucasian, 9% African-American, and 5% other. Patients were randomized to one of the following two colon preparation regimens: sodium sulfate, potassium sulfate and magnesium sulfate ...

The following important adverse reactions for bowel preparations are described elsewhere in the labeling: Serious Fluid and Serum Chemistry Abnormalities [see Warnings and Precautions ( 5.1 )] Cardiac Arrhythmias [see Warnings and Precautions ( 5.2 )] Seizures [see Warnings and Precautions ( 5.3 )] Use in Patients with Risk of Renal Injury [see Warnings and Precautions ( 5.4 )] Colonic Mucosal Ulceration and Ischemic Colitis [see Warnings and Precautions ( 5.5 )] Patients with Significant Gastro...

Sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions: Gastrointestinal obstruction or ileus [see Warnings and Precautions ( 5.6 )] Bowel perforation [see Warnings and Precaution ( 5.6 )] Toxic colitis or toxic megacolon Gastric retention Hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulf...

Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications, and consider laboratory assessments prior to and after each use. ( 5.1 , 7.1 ) Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk. ( 5.2 ) Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold. ( 5.3 , 7.1 ) Patients with renal impairment or ta...

7 DRUG INTERACTIONS Drugs that increase risk of fluid and electrolyte imbalance. ( 7.1 ) Pediatric use information is approved for Braintree Laboratories, Inc.’s SUPREP BOWEL PREP KIT (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution. However, due to Braintree Laboratories, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information....